Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Time Comparison of Interventions on Bowel Programs in Spinal Cord Injury

8 de setembro de 2026 atualizado por: Casa Colina Hospital and Centers for Healthcare

Time Comparison of Bisacodyl Suppository, Enemeez and Peristeen on Bowel Programs in Patients With Diagnosis of Spinal Cord Injury and Neurogenic Bowel

The goal of the study is to find out which of three different options (a suppository, a mini enema, or a transanal irrigation device) takes the least amount of time for completing bowel program amongst those who have spinal cord injuries with a neurogenic bowel. The main questions this study aims to answer are:

  • Does one of these tools meaningfully reduce the amount of time people with spinal cord injury need to complete their bowel programs?
  • Does one of these tools meaningfully reduce the number of times someone might experience incontinence or constipation?
  • Are participants satisfied in using these devices, and would they prefer to use the same tool at home? Researchers will compare the answers to these questions between the three different tools to improve quality of life for patients while improving the efficiency of the care provided.

Participants in this study will:

  • Be enrolled in one of these options depending on when they are admitted to Casa Colina Hospital
  • Will receive the same tool for their bowel program for the majority or entirety of their stay
  • Will have a tracking sheet placed in their rooms for nursing to record when bowel program started and when it was completed
  • Will receive questionnaires when they enroll and when they finish the study on their experience with the tool and how likely they would be to use it at home

Visão geral do estudo

Descrição detalhada

The aim of the study is to guide clinical practice with the goal of reducing burden of care and improving patient experience with bowel program. The study specifically aims to determine the difference in time spent on bowel programs with either Suppository, Enemeez or Peristeen. This study aims to advance the process of bowel programs, which currently is a large time cost for our staff. By making bowel programs more efficient, we will allow our nursing staff to devote more time to other aspects of care while improving both patient and staff satisfaction. Ultimately, determining the most efficient bowel management for patients with diagnosis of spinal cord injury and neurogenic bowel will improve the continuum of care.

All patients admitted to inpatient rehab unit will be reviewed for diagnosis of spinal cord injury with reflexic neurogenic bowel. From this population we will exclude according to our exclusion criteria. Participants will then be recruited from these patients.

The primary goal of this study is to determine which intervention produces the most time effective bowel program: suppository, Enemeez or Peristeen. The study will consist of 3 cohorts of participants. Participants will be placed in a cohort based on the date of bowel program initiation. Each month will be assigned a different intervention type, and all participants with bowel program initiated during that month will be using the assigned intervention. During the bowel program nursing staff will document time suppository or Enemeez is given. In the case of Pertisteen, the nurse will document the time out of bed instead. The staff will also document the time bowel evacuation is complete and if there has been any need for intervention to treat constipation in the last 24 hours. If a participant is on a program at the time of cohort transition, that participant will remain on their established program.

Our secondary outcome is effectiveness of treatment which will be assessed by episodes of bowel incontinence and constipation. This will be evaluated by a chart review. We will note episodes of bowel incontinence and episodes of additional orders to address constipation (e.g. abdominal xray with indication of constipation, Relistor, additional oral medications, etc.)

The tertiary outcome of the study is to assess patient satisfaction and anticipated feasibility for home use. This will be assessed via questionnaire made for this study utilizing the Theoretical Domain Framework and Consolidated Framework for Implementation Research. Questionnaires will be distributed upon enrollment and after the intervention period, which may differ to discharge or several days prior to discharge depending on the bowel program chosen.

Following participation in treatment, patients will be transitioned to a bowel program that is accessible at home as prescribed by their physician.

Tipo de estudo

Intervencional

Inscrição (Estimado)

30

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  • admission to acute rehab inpatient unit
  • diagnosis of spinal cord injury
  • reflexive type neurogenic bowel requiring bowel program with suppository and digital stimulation

Exclusion Criteria:

  • anal or rectal stenosis
  • active inflammatory bowel disease
  • acute diverticulitis
  • colorectal cancer
  • ischemic colitis
  • rectal surgery within the last 3 months
  • endoscopic polypectomy within the last 4 weeks
  • areflexic bowel
  • severe autonomic dysreflexia

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Pesquisa de serviços de saúde
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Suppository
Bowel Program managed via Suppository (current standard of care at Casa Colina Hospital)
The patient will receive a suppository 15-20 minutes prior to being transferred to toilet. Then while on the toilet patient will receive multiple digital stimulations 5-10 minutes apart to trigger the bowel reflex until bowel program is completed.
Comparador Ativo: Enemeez
Bowel Program via use of the Enemeez mini enema device
The patient will receive the 5mL enema then be transferred onto the toilet. If no evacuation occurs within 15 minutes, then while on the toilet patient will receive multiple digital stimulations 5-10 minutes apart to trigger the bowel reflex until bowel program is completed.
Comparador Ativo: Peristeen
Bowel Program via the Peristeen Transanal Irrigation tool
The Peristeen device will be prepared prior to sitting the participant on the toilet. The lubricated rectal catheter will be inserted, and the retention balloon will be gently inflated to ensure a rectal seal. The irrigation pump will then pump water into the rectum. The balloon will be deflated and the catheter removed to allow for emptying of the water and stool. The catheter will be discarded.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Time required to complete bowel program
Prazo: Every morning for approximately two hours, from enrollment and lasting 21 days
During the bowel program nursing staff will document time suppository or Enemeez is given. In the case of Pertisteen, the nurse will document the time out of bed instead. This will be done manually via a paper chart that is placed in the patient's room. The staff will also document the time bowel evacuation is complete and if there has been any need for intervention to treat constipation in the last 24 hours.
Every morning for approximately two hours, from enrollment and lasting 21 days

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Effectiveness of treatment intervention
Prazo: Assessed every morning via chart review from enrollment and lasting 21 days
Assessed by episodes of bowel incontinence and constipation. This will be evaluated by a chart review. We will note episodes of bowel incontinence and episodes of additional orders to address constipation (e.g. abdominal xray with indication of constipation, Relistor, additional oral medications, etc.)
Assessed every morning via chart review from enrollment and lasting 21 days

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Patient satisfaction and anticipated feasibility for home use
Prazo: Upon enrollment and again at 3 weeks
Assessed via questionnaire made for this study utilizing the Theoretical Domain Framework and Consolidated Framework for Implementation Research. The questionnaire will assess domains of patient satisfaction and feasibility for home use utilizing a 5-point Likert Scale from "Strongly Disagree" to "Strongly Agree." Higher scores will indicate higher satisfaction and feasibility.
Upon enrollment and again at 3 weeks

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Diretor de estudo: Emily Rosario, PhD, Casa Colina Hospital and Centers for Healthcare

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

4 de setembro de 2026

Conclusão Primária (Estimado)

4 de julho de 2027

Conclusão do estudo (Estimado)

4 de agosto de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

1 de setembro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

8 de setembro de 2026

Primeira postagem (Real)

14 de setembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

14 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

8 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Se inscrever